The trial met its primary efficacy endpoint by showing a significantly lower ‘Total Combined Rhinitis Score’ (TCRS) when compared with patients who received placebo. The trial also showed that the treatment was well tolerated and had a favourable safety profile.
ALK’s president and CEO Jens Bager said these results mark another step on our journey towards globalising ALK’s portfolio of SLIT-tablets.
"Our partnership with Torii continues to progress rapidly and we are getting closer to a launch of these products in the world’s second largest pharmaceutical market," Bager added.
The trial was initiated by Torii in 2012 as a randomised, multi-centre, placebo-controlled, double-blind comparative trial, looking at both the safety and efficacy of the drug in patients with house dust mite-induced allergic rhinitis.
A second, parallel trial, looking at safety and efficacy in house dust mite-induced allergic asthma, was initiated at the same time and is expected to report in the coming months. In all, approximately 1,800 patients participated in the two trials, the results of which will determine whether Torii will submit a New Drug Application in Japan.